Stryker Corporation: Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S

Hazard

There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

Details from the source

Reason for recall: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached. Distribution: US Nationwide distribution. Quantity: 182,344 total units Lot/code info: 5400-212-004S UDI-DI: 07613154340842, Lot Numbers: 2024011914; 5400-222-004S UDI-DI: 07613327359473, Lot Numbers: 2024021212 2024052813

UPC codes

07613154340842, 07613327359473

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.